510(k) K262043 · DXT Injector And Syringe, Angiographic
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
| Applicant | Bayer Medical Care, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Oct 6, 2026 |
| Received | Jun 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262043
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.